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Interleukin (IL)-1 Blockade in Acute Heart Failure (Anakinra ADHF)

NCT01936844 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-05-05

Study results available
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Summary

Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure with the aim to quench the acute inflammatory response, as measured by the area-under-the-curve for C reactive protein over 14 days.

Conditions

Interventions

DRUG

Anakinra (high dose)

Anakinra 100 mg daily twice daily for days 1, 2, and 3

DRUG

Anakinra (standard dose)

Anakinra 100 mg daily for days 4-14

DRUG

Placebo

Placebo twice daily for days 1, 2, and 3

DRUG

Placebo

Placebo daily for days 4-14

Sponsors & Collaborators

Principal Investigators

  • Benjamin W Van Tassell, PharmD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01936844 on ClinicalTrials.gov